JXH · Methyl Methacrylate For Aneurysmorrhaphy
Neurology · 21 CFR 882.5030 · Class 2
Overview
| Product Code | JXH |
|---|---|
| Device Name | Methyl Methacrylate For Aneurysmorrhaphy |
| Regulation | 21 CFR 882.5030 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071776 | ANEUROPLASTIC, MODEL 43-1290 | Codman & Shurtleff, Inc. | Jul 26, 2007 | SESE |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | Karlin Technology, Inc. | Jun 17, 1988 | SESE |
| K873688 | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL | Dentsply Intl. | Oct 26, 1987 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 1 clearance
- Dentsply Intl. — 1 clearance
- Karlin Technology, Inc. — 1 clearance
